Disposable Nitrile Examination Gloves

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font. July 30, 2021 Shenzhen Shiqiao Science and Technology Co. LTD Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China Re: K211264 Trade/Device Name: Disposable Nitrile Examination Gloves Regulatory Class: 21 CFR 880.6250 Product Code: LZA Dated: July 8, 2021 Received: July 14, 2021 Dear Boyle Wang: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K211264 Device Name Disposable Nitrile Examination gloves Indications for Use (Describe) The Disposable Nitrile Examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary-K211264 This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR 807.92. #### 1.0 submitter's information Name: Shenzhen Shigiao Science and Technology Co.LTD Address: Unit 2105 ,Tower D. Galaxy World phase II, Minle community ,Minzhi street , Longhua District ,Shenzhen, Guangdong Province, 518000, China Phone Number: +86-18922802487 Contact: MIKKI WAN Date of Preparation: 2021.04.21 #### Designated Submission Correspondent Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Tel: +86-21-50313932 Email: Info@truthful.com.cn #### 2.0 Device information Trade name: Disposable Nitrile Examination gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL #### 3.0 Classification Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital #### 4.0 Predicate device information | Manufacturer: | Ever Global (Vietnam) Enterprise Corp | |---------------|-------------------------------------------------------------------------------------| | Device: | Disposable Powder Free Nitrile Examination Glove, White/<br>Blue/ Black/ Pink Color | {4}------------------------------------------------ #### 510(k) number: K171422 #### 5.0 Intended use The Disposable Nitrile Examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner. #### 6.0 Device description The proposed device is Powder Free Disposable Nitrile Examination gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile. #### 7.0 Summary comparing technological characteristics with predicate device | Item | Proposed device | Predicated device | Remark | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | 510(k) number | K211264 | K171422 | | | Product Code | LZA | LZA | Same | | Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same | | Class | I | I | Same | | Intended Use | The Disposable Nitrile<br>Examination gloves is a<br>disposable device intended<br>for medical purposes that<br>is worn on the examiner's<br>hands to prevent<br>contamination between<br>patient and examiner. | The Disposable Powder<br>Free Nitrile Examination<br>Glove, White/Blue/Black/<br>Pink Color is a disposable<br>device intended for<br>medical purposes that is<br>worn on the examiner's<br>hands to prevent<br>contamination between<br>patient and examiner. | Same | | Powdered or Powered free | Powdered free | Powdered free | Same | | Design Feature | ambidextrous | ambidextrous | Same | | Labeling Information | Single-use indication,<br>powder free, device color,<br>device name, glove size<br>and quantity, Disposable<br>Nitrile Examination gloves,<br>Non-Sterile | Single-use indication,<br>powder free, device color,<br>device name, glove size<br>and quantity, Disposable<br>Powder Free Nitrile<br>Examination Glove,<br>Non-Sterile | Same | Table1-General Comparison {5}------------------------------------------------ | Predicate | Designation | Size | | | | | Tolerance | |-----------------|----------------|------|-----|-----|-----|-----|-----------| | Device(K171422) | | XS | S | M | L | XL | | | | Length, mm | 230 | 230 | 230 | 230 | 230 | min | | | Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 | | | Thickness, mm: | | | | | | | | | Finger | 0.05 | | | | | min | | | Palm | 0.05 | | | | | min | | Proposed Device | Designation | Size | | | | | Tolerance | | | | S | M | L | XL | | | | | Length, mm | 220 | 230 | 230 | 230 | | min | | | Width, mm | 80 | 95 | 110 | 120 | | ±10 | | | Thickness, mm: | | | | | | | | | Finger | 0.05 | | | | | min | | | Palm | 0.05 | | | | | min | | Remark | SAME | | | | | | | ## Table2 Device Dimensions Comparison ## Table3 Performance Comparison | Item | Proposed device | Predicated device | Remark | | |------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|------------------------|------| | Colorant | blue | White/Blue/Black/Pink | Analysis1 | | | Physical<br>Properties | Before<br>Aging<br>Tensile<br>Strength | 14MPa, min | 14MPa, min | SAME | | | Ultimate<br>Elongation | 500%min | 500%min | SAME | | | After<br>Aging<br>Tensile<br>Strength | 14MPa, min | 14MPa, min | SAME | | | Ultimate<br>Elongation | 400%min | 400%min | SAME | | | Comply with ASTM D6319 | | Comply with ASTM D6319 | SAME | | Freedom from Holes | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | SAME | | | Powder Content | 0.04 mg/glove | Meet the requirements of ASTM D6124 | SIMILAR | | Analysis1: The proposed device has different colorto the predicate device, but all proposed devices are conducted the biocompatibility test, the test results shown that the color difference do not effect the safety of proposed device {6}------------------------------------------------ | Item | Proposed device | Predicated device | Remark | |--------------------|------------------------------------------------------------------------------------------------------|----------------------------|---------| | Material | Nitrile | Nitrile | SAME | | Biocompatibility | Irritation<br>Under the conditions of the study,<br>not an irritant | Comply with<br>ISO10993-10 | SAME | | | Sensitization<br>Under conditions of the study, not<br>a sensitizer. | | | | | Cytotoxicity<br>Under conditions of the study, did<br>not show potential toxicity to L-929<br>cells. | Comply with<br>ISO10993-5 | SIMILAR | | Label and Labeling | Meet FDA's Requirement | Meet FDA's<br>Requirement | SAME | #### Table4 Safety Comparison #### 8.0 Discussion of non-clinical and clinical test performed Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards: ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. ASTM D6319-19,Standard Specification For Disposable Nitrile Examination gloves For Medical Application. Clinical testing is not needed for this device. {7}------------------------------------------------ ## Table 5 Performance Data | Test Method | Purpose | Acceptance Criteria | Results | Status | | | | | | | | | | | | | | | | | | |-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------|--|--|-----------------------------------------------------------|--|--|--|--|-----------------------------------------------------------------------------------------|--|--|--|--|-----------------------------------------------------------------------------------------|--|--|--|--| | Watertight:<br>ASTM D5151<br>(Standard Test<br>Method for Detection<br>of Holes in Medical<br>Gloves) | To detect<br>holes that<br>leak water<br>and thereby<br>compromise<br>the<br>usefulness of<br>the glove. | Immediately inspected the glove visually for<br>water leakage. Let the glove hang for 2 min and<br>again inspect for water leakage.<br>Batch size: 35000, Sample size: 125 pcs,<br>Inspection level: I, AQL: 2.5, Ac=7, Re=8 | During the test, 0 piece was found with leaks.<br>Hence it falls within the acceptance criteria. | Pass | | | | | | | | | | | | | | | | | | | Physical Properties:<br>ASTM D412<br>(Standard Test<br>Methods for<br>Vulcanized Rubber<br>and Thermoplastic<br>Elastomers—Tension<br>) | To evaluate<br>the tensile<br>(tension)<br>properties of<br>glove. | Batch size: 35000, Inspection level: S-2,<br>Sample size: 8 pcs,, AQL: 4.0, Ac=1, Re=2 | | Pass | | | | | | | | | | | | | | | | | | | | | Before Aging | After Accelerated<br>Aging | | | | | | | | | | | | | | | | | | | | | | Tensile<br>Strength Ultimate<br>Elongation ≥14MPa ≥500% | | | | | Tensile<br>Strength Ultimate<br>Elongation ≥14MPa ≥400% | | | | | Tensile<br>Strength<br>(Average) Ultimate<br>Elongation<br>(Average) 16.41MPa 540.56% | | | | | Tensile<br>Strength<br>(Average) Ultimate<br>Elongation<br>(Average) 16.41MPa 532.98% | | | | | {8}------------------------------------------------ | Physical<br>Dimensions:<br>(ASTM D<br>3767-03(2014)).<br>Standard Practice for<br>Rubber—Measurem<br>ent of Dimensions | To measure<br>the length,<br>width and<br>thickness of<br>glove | Length | S | Min. 220 mm | Length | S | Min. 243 mm | Pass | |------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------|--------|-------------|------------------------------------------------|--------|-------------|------| | | | | M | Min. 230 mm | | M | Min. 249 mm | | | | | | L | Min. 230 mm | | L | Min. 251 mm | | | | | | XL | Min. 230 mm | | XL | Min. 271 mm | | | | | Width | S | 80±10mm | Width | S | 86-89mm | | | | | | M | 95±10mm | | M | 97-99mm | | | | | | L | 110±10mm | | L | 106-109mm | | | | | | XL | 120±10mm | | XL | 110-120mm | | | | | Thickness | Finger | Min.0.05 mm | Thickness | Finger | Min.0.08 mm | | | | | | Palm | Min.0.05 mm | | Palm | Min.0.08 mm | | | Residual Powder:<br>ASTM D6124<br>(Standard Test<br>Method for Residual<br>Powder on Medical<br>Gloves) | To determine<br>the amount of<br>residual powder and<br>non-powder<br>solids found<br>on gloves. | Less than 2 mg per glove | | | Sample size : 5 pcs<br>Result: 0.04 (mg/glove) | | | Pass | {9}------------------------------------------------ ## 9.0 Conclusion The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.